EPISODE 25: NICOLAS POUTRAIN-ROYER, GENERAL MANAGER AMERICAS AT EDAP TECHNOMED INC

Episode’s transcript

Julio Martinez: 0:04

Welcome to the Latin MedTech Leaders Podcast. This is a weekly conversation with MedTech leaders who have succeeded in Latin America.

Julio Martinez: 0:14

Welcome Back to the Latin MedTech Leaders Podcast today. Our guest is Nicola Ra . Hey, Nicola , thank you for joining us today. How are you doing today?

Nicolas Poutrain: 0:25

Hey, Julio, how are you? Thank you very much. Thank you for , uh, welcome Mik to talk today and , uh, and , uh, and being there with you.

Julio Martinez: 0:33

Excellent, Nicola . So , uh, listeners, Nicola Ra is General Manager Americas of eap Teched , the US subsidiary of the medical device, French Manufacturing Company, eap , TMS. The company specializes in innovation in non-invasive therapies around ultrasound and laser. Prior to that, Nikola was I Dap , VP of sales for Europe, latam and Canada from 2008 2019 . And prior to that, Nicola spent nearly a decade for a technical industrial company doing international business development and had global responsibilities, including Latin America. Throughout his career, Nikola had to open new markets in his territory, starting with the selection of the right distributor partners and had to deal with regulatory huddles to get his products locally approved. For Nikola , this was a relatively easy process in Europe, but quite difficult and time consuming in Latin American countries. Nikola believes that the main difficulty in penetrating a new market lays in convincing the physicians and medical associations about the cost benefit of the use of innovative medical technologies. Nikola has a master's degree in business administration from the Rene , uh, business school in France, and the take the Monterey in Mexico, and it speaks fluent French, English, Spanish, and Portuguese. So I'm really delighted to have , uh, Nikola in the show today , and I look forward to our conversation. So, Nicholas , let's get started , uh, with , uh, you telling listeners about your journey to Latin America. How do you get involved with the region since you are from France?

Nicolas Poutrain: 2:23

Well , uh, initially , uh, in , in , uh, in my first like , uh, decade with , uh, EAP TMS from , uh, 2008 to 2019 , uh, I was based in France. Now I'm based in, in the us but the way it started , uh, was , uh, quite easy. Uh , I was recruited , uh, by , uh, my company , uh, to open new markets, mainly , uh, Europe again, and , uh, and , uh, Latin America. And because I had already experience , uh, in , uh, in Latin America, and , uh, and because I was speaking , uh, uh, Spanish and, and Portuguese, well , that's how I ended up in , uh, in , uh, joining my company. And , uh, and I had to , uh, start , uh, uh, off , uh, the, the, the market in Latin America from , uh, almost scratch. We only had , uh, one partner , uh, I remember in , uh, in Mexico. And then, well , based on , uh, on , uh, uh, the, the knowledge I had and the experience I had with , uh, with Latin America, well , I, I, I just had to make some research on , uh, how to , um, to find partners in , uh, in South South America who had some experience , uh, in , uh, in our medical industry , uh, in which we are , uh, specialized mainly in , uh, in the urology , uh, specialty. And , uh, and I mostly spent , you know, around I would say six to seven , uh, times a year traveling to , uh, the different countries and , uh, and , uh, helping my , uh, my distributors developing the market.

Julio Martinez: 4:09

Excellent, Nicholas . All right , so let's get started , uh, with , um, some trends that you see in Latin America. What major trends do you see happening in the region that are relevant to our discussion today?

Nicolas Poutrain: 4:25

Well, I would say that in the past 10 years, we had , uh, a real global change in, in , uh, Latin America. The , the, I would say that the continent really opened a lot the market to Europe and , uh, in , even to the US and even more than that, to new technologies. When I joined the company back in, in 2008, I remember still there was a big delay, a big lack of innovation in all these countries. And they had technologies , uh, aging technologies , uh, uh, available. And , uh, it's been pretty how , uh, in the past 12 years, the market and , and thanks to also , um, the professionalism of , uh, the medical companies , uh, available and present in these markets, made a good job to help , uh, Latin America to really get access to , um, to the latest technology , uh, available still , uh, you have in Latin America a lot of political discrepancies and, and issues. I would say that , um, between 2008 , uh, till 2016, if we , uh, get rid , uh, of , uh, Venezuela, the situation was, was , uh, really promising. And , uh, and, and really the market was , uh, evolving , uh, uh, very fast and positively. And I would say that in the past , uh, year and a half since , uh, Argentina went down with the big , uh, big collapse in their, in their economy , uh, Latin America, well slowed down again , uh, in , uh, in its economy. And we have several o of the, of the main countries like Brazil, Chile, Mexico, and Argentina, who are facing , uh, difficulties. And , uh, and of course the COVID-19 , uh, today is not helping , uh, the market to , uh, to restart , uh, a as quick , uh, as we would like. But , uh, I , I think that , uh, in, in the very long term , I mean , uh, uh, these are exciting markets with , uh, with a lot of potential and where it's not that hard to , uh, to make business. On the contrary , uh, Latin America is , uh, is uh , is a country where people , uh, uh, like to do business and , uh, and , uh, in an easy way, I would say.

Julio Martinez: 6:48

Okay, good, good. So , um, you kind of , uh, answered this question already, but that's a question that I , this is a question that I usually ask my guests . What's your overall perception of Latin America as a place to either conduct medical device, first in human or early feasibility, clinical research, or to commercialize medical technologies? And I understand that your experiences more in the commercialization, but , uh, if you wanna elaborate a little bit more, that'll be fantastic for the listeners.

Nicolas Poutrain: 7:17

Yes, and , uh, and don't get me wrong, even on, on the clinical side , uh, it's a , it's a very important, I would say that today the level of , uh, clinical experience and evidence available, or you have in Latin America is almost as good as what you have , uh, in, in the main , uh, northern, I I would say countries like the US and , and Europe. You've got like , uh, in Brazil, Argentina, and, and Chile, and even Mexico, a level of , uh, medicine, which is extremely good. And again, for, for the commercialization of , uh, of equipments , uh, they were asking me, you've got, you've got a lot , uh, of potential today to , uh, to sell your equipments to , uh, to these countries. They are really key , really looking forward , uh, being equipped with , uh, the latest , uh, technologies , uh, available.

Julio Martinez: 8:11

Okay, well said . Alright , Nicholas , let's dive into your practical experience with the commercialization of medical technologies in Latin America. I like to hear your thoughts and , uh, suggested best practices about several topics. Uh , first of all, in what countries , uh, have you worked in Latin America?

Nicolas Poutrain: 8:32

So in , in the past , uh, 15 years , uh, uh, I must say that I almost traveled in any single country in Latin America, from Mexico to Argentina. But we can , uh, say again , uh, Dominican Republic, Honduras , Salvador, Panama, and of course the big ones , uh, which are Brazil, Argentina, Chile , uh, without forgetting smaller ones like per or Ecuador , uh, it , it's all linked to , uh, the products. So we, we are selling, we have , um, worldwide limited, I would say market for our equipments. Our equipments are all worth like 500,000 to $800,000. So, which is quite expensive. And , uh, uh, I can tell you that worldwide , uh, almost any hospital, having a urology department as my company, many works and deals with a urology own , uh, some of our equipments. So it makes it easy when, when you've got to develop a , a , a market, you know that once you, you, you enter a new country and go to one of their main hospital with the urology department, this will be a target for you. So that's why so far in, in South America, I've been almost , uh, everywhere , uh, in the past 12 years.

Julio Martinez: 9:55

Fantastic. Nicholas , what an experience, huh? I'm sure. Alright , so we know that obtaining regulatory approvals and market clearances is a big hurdle , uh, for many companies. So I love to expand open your experiences , uh, here. I'm sure you've been involved in the regulatory approval process of, of your products , uh, right?

Nicolas Poutrain: 10:16

Yes, yes. It's time. Uh , I've , uh, entered the new market, yes.

Julio Martinez: 10:21

Okay. So let's go country by country. Um, if you don't mind, let's discuss the regulatory approval process and, and, and if you could tell us some tips or traps to avoid in each of these countries would be fantastic. So let's start with Mexico. What do you think about KA priest and the approval process in Mexico?

Nicolas Poutrain: 10:41

I would say that KA priest , uh, in the past , uh, 12 , uh, 12 years has been maybe the, the main hurdle in all Latin America. CORIs is very, is a very slow process. Everybody in the industry at the hub , uh, I remember back in, in, in 2012, roughly when the implemented , uh, a fast track process linked to , uh, FDA approval. Warren , uh, they told us that in a thread , let's say a trail of, of two, three months, we would be in a position in case we had FDA approval of getting , uh, uh, coffee press approval. And this has never been , uh, the reality of , uh, of anybody. We are lucky in our company just because our products are so much , uh, specific to urology. And because we don't have a lot of competition. We had , uh, our first equipment sold , uh, in the social security of Mexico ims , mainly back in the nineties. As , uh, in that period , uh, French companies were doing international were , uh, supported a lot by , uh, our local governments. And that's how we, we got started in Mexico and we got , uh, codes and , uh, coffee press , uh, approval for our products a long, long time ago. Regardless of this, in the past 10 years, we had new products coming in, our catalog, our brochures, and , uh, and it's been quite a challenge to , uh, get them approved. We, we, we did it, but it took us roughly two to three years to , uh, to get our products , um, uh, approved.

Julio Martinez: 12:19

Wow. Hmm . Okay. So what about Brazil?

Nicolas Poutrain: 12:23

So, Brazil , uh, same process as , um, Mexico. I would say that Mexico was more a country where it's difficult to , to , um, to get approved also because the people within the coffee press are not , uh, very helpful. Sometimes wars in Brazil , uh, it's more , uh, I would say the organization that slows slow, sorry , everything. But there were , uh, many progresses , uh, with Envisa in Brazil in the past 12 years. Uh, when I joined the company, I remember , uh, uh, getting started with the approval of , uh, one of our best seller , which is a product called , uh, focal one. It treats , uh, prostate cancer. And it took us at that time , uh, roughly , um, just three years, I would say two to three years to get the product involved , uh, and approved. But then Envisa also put some more hurdles as the put in place. I remember back in, in , uh, 2012 , uh, process called the GMP, which has to , to do with the good manufacturing processes. So it involves when you want to sell in Brazil or products , uh, an obligation for your company to get audited by the Brazilian authorities in your company to get , uh, approved on your , uh, on your quality management. And , uh, this has been quite a challenge for , uh, most of the companies in the medical industry worldwide as , uh, when it got started, the end visa . So the MOH , uh, of Brazil was not prepared for this, I would say big wave. And they had two , uh, two little , uh, teams available , uh, too few teams available , uh, of people to , uh, to make the audits worldwide . So you had to wait almost , uh, two years to get your company audited. And the price was also , uh, quite prohibitive as you had to pay. I remember it was in, in real 40,000 reel , uh, 40,000, yes. Real , it's now 100,000 reel . So it got started with roughly $15,000. And now the price to get , uh, your company , uh, being GMP approved is roughly , uh, 30,000 , uh, dollars today. But it's bettering the system is really bettering now. And Visa got , uh, well managed to , uh, employ a lot more people to do it, to also deploy some , uh, agreements worldwide with certification companies in the US and in Europe. That instead of, of course , uh, having to send your Brazilian force to , uh, for instance, our company to do now , you can , uh, just rely on , uh, on a partner in Europe, for instance, to do the job for you and get the company approved.

Julio Martinez: 15:18

Okay. Very good. Alright , so what about Columbia ?

Nicolas Poutrain: 15:22

Columbia is not a difficult , uh, so much a difficult process. We've done that , uh, many times with , uh, some of our products. I would say that , uh, I forgot the name of the MOH of , uh, of Columbia . I dunno if you know it.

Julio Martinez: 15:34

In Vima .

Nicolas Poutrain: 15:34

In Vima , yes, in Vima has been, to me one of the easiest process available. So the way it works in , uh, in Colombia , normally you've got to do it through , uh, your distributors. Uh , we did not talk about it before , uh, with you, but in South America, you can in some way apply for , uh, a registration of your products as a company. But if you've got, of course, a subsidiary present into the territory, in the exception maybe of , uh, of Chile, where you've got nothing, and Brazil, you can , uh, you can apply , uh, as a sole company even if you are not present. But I would say that in 70% of the countries , uh, or 80% in South America, you have to have, or a subsidiary in the country, or to have a distributor that will do the registration in its name and not in your , so for instance, in Colombia , I've got a distributor now, a company , uh, called Technology Medicas , and they are the owners of my registrations certificates , uh, for Colombia . And the process so far took roughly, I would say, six to eight months to , uh, to get approved. Nothing very complicated. One, information can that can interest , uh, some of , uh, the , uh, uh, auditors is that when, for instance, you are in a position of changing your distributor, there is a pathway , uh, that enables your former distributor to transfer , uh, at really a minimum cost , uh, the ownership of your , um, register to the new company. And, and the process takes roughly two to three months to be fulfilled.

Julio Martinez: 17:21

Well, I may add something here, Nicholas . The way it works in Columbia is that Columbia allows foreign companies to hold the registration certificate under its name. In other words, if you are a French company or American company, you can have ownership of registration certificate under your foreign company's name in France or the us and that you don't have to necessarily have the distributor control or own the registration certificate because the validity of the registration certificate in Colombia is one of the longest in Latin America for a medical device at least is 10 years. So if a company lets a distributor to hold or to own and , and control the registration certificate, you are granting the distributor in a way exclusivity for 10 years. Because if you engage a distributor and you don't have any issues with distributor, and the relationship is fine, everybody's happy, the distributor is making money, you are making money, everything is good. But if you run into troubles with the distributor, the distributor doesn't meet the quota or does something illegal, or it goes out of business, which happens a lot in Latin America, then you have to somehow transfer the registration certificate to another competing distributor in, in Columbia and or other countries in Latin America. And that's when you realize that is not necessarily a good practice to have the distributor own and control the registration certificate, because sometimes they don't wanna transfer the registration certificate, or they ask you for money in exchange for transferring their registration, or they went outta business and the company's no longer in existence. So there's no way to get ahold of anybody in the company. So that's why now we have , um, consultants, third party consultants, or third party registration holders in many countries in Latin America, where you can rely on them and pay a , an annual fee or monthly fee for them to hold or to have their local name. Yes, their local companies name in, in the register certificate. So you can easily control everything and you can easily transfer to any other distributor at will .

Nicolas Poutrain: 19:50

Yes, that's true. Like ergo , like Yes,

Julio Martinez: 19:52

Exactly.

Nicolas Poutrain: 19:53

I fully agree with you, and we've done through , and you are raising a very important , uh, question there. And that's also why we took that way. There are like two main variables to me that make a company like us deciding whether to go through one of these , uh, consultants or to go through a distributor. First of all, the cost, the dollars, it's costful not that much, but it's a cost to register product somewhere. Uh , of course you've got these companies that will do it for you, but you've got to have in your headquarters, HQs the team also that will be there as a support to make sure that, you know, they are making the link , uh, with the , the local consultant for the updates that are happening, you know, all the time on your products. And from the side also of , uh, the local , uh, MOH. And also you've got to consider , uh, the products you are selling. If you are selling disposables, it makes sense to do it that way because you are normally more in a position of changing, you know, your distributor more often. That if you are like our company selling , uh, capital equipments, our capital equipments are big investments require a lot of investments from our distributor. And also knowledge and training for this reason . Sometimes the , uh, fact that you give your distributor the ownership of your register, make them feel more comfortable with your products. Of course, as you said, in case I want to change, it makes it a bit more difficult. But if you are doing things correctly, you know, and uh, and uh , try to terminate with a distributor , uh, gently, you know, you won't face so many problems. And because in capital equipment, it takes so long sometimes to make a sale, and the processes are from six months sometimes to one, two years in this , in the ballpark, you know, of our equipments from 500 , uh, thousand dollars onwards. In that case, you know, you've got the time to really ap apply for a new register , uh, or find a new distributor that will do it for you. And of course , uh, go through, as you said it , a consultant like ergo , for instance, who who will do it for you. Yes. But , uh, but again, it's important to have your team, a big team or so of regulatory , uh, in your regulatory department , uh, of people available to cope with , uh, with , uh, these issues.

Julio Martinez: 22:38

Yes, that's, that's a good point. The other aspect to keep in mind , uh, Nicola , is in a country like Columbia , for example, where you can only name one distributor, actually it's not even a distributor, you can only name an importer of record. So there's a big difference between an importer record and a distributor. And most of the times they are the same. A distributor can be an importer record, but an importer not necessarily can be a distributor.

Nicolas Poutrain: 23:08

Yes.

Julio Martinez: 23:09

So my point with all this is that if you have , uh, one distributor in the whole country, fine. You can have the registration under your company's name in France, for example, or the US or the registration under the local distributor's name, and the distributor will be besides the title holder of the registration, they can be the importer of record. Okay? And you are good, but if you wanna have more than one distributor in a country like Columbia , for example, again , that only allows one I importer record to be named in the researcher certificate, then you are faced with a challenge. Yes. Who do I name as my importer of record if I wanna have five distributors? 'cause Columbia is a country of 50 million people. It's the third largest country in Latin America. It's the third largest economy has , uh, roughly five different regions that are very separate , uh, geographically diverse and culturally diverse. So some companies start with just one distributor, and then they realize that they want to have presence beyond Bogota because most of the distributors are in Bogota. Yes. And that's where 70% of the sales happen in the country. But if you wanna cover the other 30% of sales, the other parts of the country, like in the Caribbean coast , Barranquilla in the coffee growing region, Meine in the south , west Cali, or in the East Buca manga, then you are faced with a challenge. So who is gonna be your importer record and who is gonna be your distributor? So

Nicolas Poutrain: 24:42

Yes, I fully agree

Julio Martinez: 24:43

These type of things , uh, needs , need to be taken into consideration when developing a strategy in a country.

Nicolas Poutrain: 24:49

Yes. And again, it has to do with the kind of products you sell, whether you sell yes, consumables or , uh, so dedicated for like a , a massive market or like us , uh, capital equipments , uh, when we are discussing of capital equipments , uh, like ours , uh, again, o of this , uh, value you, you choose the other option. And , uh, in a way it leads us to the distributors, but I forgot to mention our strategy with our company, because our market is limited to a number of equipments per country. Uh , our equipments are, have a lifespan roughly of , of 10 years. So it involves selling the equipment and then , uh, selling the hospitals , uh, service contract to maintain the equipment during a period of 10 years. So that's , uh, how we get our revenue and because our market is limited and is not in thousands , uh, uh, units for each of these countries, our strategy to have exclusive distributors in each of our countries, not only in Latin America, but worldwide. So that's why at the end, and you are right, this strategy has an implication at the end on the way we will manage the reg regulatory, the sh the, the selection of our distributors, everything

Julio Martinez: 26:11

Very well said. Yes, agree. Alright , uh, Nicholas , let's quickly cover Peru, Argentina, and Chile. What do you have to say about these three countries ,

Nicolas Poutrain: 26:20

Uh , Peru, you say Peru, Chile and

Julio Martinez: 26:22

Argentina.

Nicolas Poutrain: 26:23

And Argentina, what could I say? They don't always like each other. That's for , uh, history. But in business , uh, they can be good partners, of course. Number one is Chile , uh, in terms , uh, actually of , uh, how do you say in English, isness to , uh, is to get to the market. Isness. It's a good one . Yes. Yeah. To get to the market, it's very easy. You have, you have absolutely , uh, from Europe and the us no constraints, regulatory constraints to get to Chile. And that's why , uh, Chile is always a bit the test market for , uh, companies from , uh, north America and Europe when you want to go to Latin America. But the country, of course, is a smaller country in terms of population than , uh, Peru and Argentina. But Chile is good, good economy, and the level of medicine of the physicians is very good. And of course, of infrastructures. Peru has been so far my most disappointed market, and that for our , um, capital , uh, devices market has been very difficult. Uh , Peru almost did not invested in capital equipments in the past 12 years from , uh, Alan Gasier president. It's been very, very difficult. We had hops and , uh, I must say that I've been to per almost , uh, twice a year in the past 10 years with a very , uh, low return on investment. I would say I , I eventually , uh, lost money in this market more than I won. But I know that some of my competitors , uh, that are more involved in the consumable , uh, market are the very good results in the past five, six years. But when it gets in, in , per the investment in products, it's , uh, you've got a , a , a needier access with consumables than with capital equipments. And as far as regulatory process, it's not very long. It takes a six to eight months, and , uh, it's not that bad, but really a country facing major difficulties. The level of the hospitals, public hospitals is very low in per, have been very much disappointed. You have, of course, some of them that attending in a better position, but, but the organization , uh, is really not that good in the public sector, again, and you've got two sectors. Uh , one is alud , which is , uh, as in Mexico, the, so social security, but the good part of it. And then you've got ssa , which is part of , uh, the , uh, minister, minister of Health , uh, where they've got less , uh, less resources, difficult country per the private side is going better. They are making investment, but it's not for a company who wants to get to South America, Latin America story . It's not , uh, a a an easy country to do business because of , uh, of <inaudible> . And then Argentina. Argentina has always been , uh, the rollercoaster, not only in the medical industry, but uh , in any industry so far. It makes people dream all the time because Argentina was one of the richest countries. And we know that when we know Latin America in the , uh, 20th century. But in the past 40 years, the problem of Argentina is this economy that goes , uh, forth and back and gets , uh, years of crisis, and then all of a sudden can get back to , uh, a striving economy , uh, during a period of , uh, two, three years where , uh, lots of investments are done. And , uh, and the level , and that's created the level of , uh, of , uh, medicine there is so good. They are very good surgeons, very good physicians. But sometimes, you know, like a year ago, in two weeks, the economy just collapses, and then the peso goes down 60 40 to 60% down, and then , uh, everything is , uh, again , uh, frozen , uh, for a certain period of time. And , uh, this is the best way to describe , uh, to describe , uh, uh, Argentina. Like , uh, in football, you , you have periods of, of , uh, full economy, full activity, and then , uh, big disappointments. And , uh, this is Argentina. The way you, you get into Argentina on the regulatory , uh, process with , uh, unad , uh, it's been very difficult in the past. It's improved still. The process can be , uh, over a year. It's long. Then once you are in the market, again, you've got to deal with a lack of resources. And it's difficult in , uh, in the consumable , uh, market as well as the capital devices market. It's not an easy market. You have, again, the best thing about , uh, about Argentina is the country and the physicians and the people. But when it comes to do the business, it's difficult.

Julio Martinez: 31:17

Excellent. Nicholas , thank you for that comprehensive description of the countries, the major countries in Latin America. So let's quickly move to another topic. Please tell us about your experience importing shipping and importing medical devices to Latin America. Is , has it been difficult? Has it been , uh, easy? Have you faced equipment held in costumes, corruption? I mean, what are your thoughts on this?

Nicolas Poutrain: 31:43

Yes . So globally, it's not that complicated. Again, to import products , uh, in Latin America, the main thing you need is to have a very good partner. If you've got the good partner, the good distributor, importer, they are the ones who have all the tips and tricks to make things , uh, happen , uh, uh, easily. The countries where you've got more difficulties to import products, it's, it's mostly due to time consuming. I would say it's Brazil and , uh, and Mexico, Brazil, because that's the way their , uh, customs organization is , uh, is organized. Uh , it makes the things difficult. But again, if you've got the right partners, it shouldn't be a problem. But , uh, you've got to get prepared. Brazil is difficult. You've got to have from your , uh, headquarters, everything ready, the labeling of your products, because anything that goes wrong in Brazil , uh, in case you import something there and your , uh, merchandise can be stuck for , uh, weeks, months, just because you did not fulfill the anything correctly. Brazil , uh, is like this, but if you do things correctly, it can be very fast. Mexico, it's different. They opened back in, in the early two southern trade , uh, free trade area with Europe, with no , uh, taxes, import taxes , duties , but they ended up at the end taxing a lot more what they call the national ion . So all the internal cost of shipping and equipment from, for instance, the Port of Cru or even the airport of Mexico, is twice more expensive than , uh, the import util , uh, themselves. And , uh, and there is a lot of corruption in , and we know that in Mexico and at all levels, like in coffee, press two , so it can make the import process in Mexico very long. I would say that Mexico is maybe the country in , uh, in all summer South America, where it's , uh, it's the most difficult process. You, you , you can face all the other countries. It takes always some time , two, three weeks, we know, but it's never really a problem. Again, the secret of everything is to make sure you've got, as a company, all the certificates , uh, of origin of your products, everything well prepared, and a good partner, you know, in your local country. And then , uh, e everything should get , uh, done very gently in a very gently manner.

Julio Martinez: 34:20

Okay, very good. Uh , Nicholas , let's move on. What about finding distributors? What are some of the best practices to find distributors in Latin America, in your opinion? How to do due diligence on them as well?

Nicolas Poutrain: 34:33

Okay, back 20 years ago, we didn't have internet. So internet , uh, of course , uh, helped a lot opening , uh, the market and , uh, the access to distributors. But the secret of everything, once you get into a market and industry, the best way to do it, you know, some people , uh, without any knowledge will , uh, get , uh, hold , you know, of their , uh, embassies that normally have, it can help sometimes that normally have a , a department, you know , uh, that helps companies finding a , a distributor in this , uh, local market. But , uh, after, well, some years of experience, I , I must say that the best way is your own experience. And once you are in a market, like for myself in urology, I know that once I've got to tap a market, there are two ways of , of finding distributors as fast or three ways as fast as possible. First of all, you can discuss with the physicians in the country. So of course, you get into, like Colombia , you go to Bogota, and you will find , like I'm doing it, a urologist who works with in one , uh, of the big hospitals. And you will just ask him, okay, I'm new in your country. You have interest , uh, in my products, who are, you know, the major and best distributors according to you in Colombia , uh, that could help me, you know, import my products and promote my products in , uh, in your country. That's one of the best way to do it. Then in the medical industry, again, you've got all these , uh, congresses , local congresses for each specialty. I I , I , I know it can be gastroenterology, urology, gynecology, whatever, cardiology. They've got their own local congresses in each of the countries in Latin America, once a year . So you can also get into one of these congresses. You just buy a pass , and you've got all the time, the main distributors displaying , uh, their products in these congresses. And that's where you can try , uh, based on their portfolio , uh, they have on their booth, you know, you can discuss with the guys and , uh, and see whether you've got an option with , uh, with , uh, one of those people. And then step by step , as you are new in a , in a market like Latin America, you can start with bigger countries like Brazil, Mexico, Colombia , and when it gets to the smaller countries, will just make sure to , uh, develop your network with your competition, which is not always your competition, direct competition, but also industries working in, in the same industry as you do, as they also have partners that they can share with you. And that's what I've been doing over the past 12 years. I'm always sharing, you know, my contacts with my , uh, competitors, indirect competitors as we are always on the same board and always, you know , uh, in the same congresses together. So according to our experience, successes, and also , uh, defeats sometimes in some markets, we share the contacts and the information so that each of us, you know, can benefit from the, the experience of the others. And if we can help finding the right guy , that can be very helpful.

Julio Martinez: 38:03

Excellent, Nicholas . All right , so let's , uh, quickly talk about go to market or market access strategies. What's been your, your strategy so far, or what strategy do you think is best, or how would you choose either of these two strategies? I mean, there are basically two ways to go to market . One is your find a distributor and you just ship products to the distributor, and you let the distributor do the work. The other one is having, besides the distributor, having a, an agent or somebody local who is representing your interest and that is supporting the work of the shooter. What do you think about these two strategies?

Nicolas Poutrain: 38:44

Um, that's also , uh, a very good question because during my past , uh, 20 years , uh, of , uh, of experience in Latin America and worldwide, I had to deal with agents and I had to deal with distributors. Again, I , I would say that all this go-to-market strategy has to do originally with the type of products you sell. When you sell capital equipments, like with you , uh, so equipments that need maintenance, you cannot do it through an agent. You need to , uh, be dealing and partnering with the company that not only , uh, owns or has a sales department, but also , uh, a service engineering department, regulatory department, everything. When you are dealing with , uh, disposables, it can be different. And according to the market you have, whether this disposable can be sold in millions or depending of course of the quantity, then you can decide whether you need a distributor or , uh, an agent, because sometimes the market can be so big for you, you can have a distributor or subagents, it depends, but this has to do really with the size of the market you want to tap. So again, the question really has to do with , uh, your product, whether and the market access to whether your market is huge. In that case, it can make sense again, to have an agent or agents and also on the products and the technical specification of your products, because again, your products requires a lot of technical knowledge and also service in that case , uh, you need to have a , a distributor more , uh, than an agent.

Julio Martinez: 40:40

Okay, very good. Or both. I mean, in some markets you may be in need of both.

Nicolas Poutrain: 40:45

Yes.

Julio Martinez: 40:46

So what about demand generation? Have you ever been involved in strategies or tactics where you support your distributor, or you invest money to generate demand directly from the end buyer to help your distributor?

Nicolas Poutrain: 41:00

Yes. So the , the way it works, again, and to me, so I've been dealing with distributors for 20 years now. There is no way a can , a distributor can do hiss job, I would say, perfectly without the full support of the manufacturer. It's impossible. Some people just think that, you know , uh, finding a distributor is the only path to your promotion of your products and to sales . And then, you know, just waiting for the distributor to do their job and to , uh, import your goods and, and sell your goods , uh, into the market. It's not working that way. The way it works between a distributor and the manufacturer is really a partnership. It's really a matter of, of trust, of creating a team. And if you want to be successful, you've got to make sure that you will understand the market as much as , uh, your , uh, distributor does. So for each of my distributors I had , uh, in the past 20 years, I've always, I've always made sure, you know, to travel as much as possible , uh, in these countries and to be in touch with them , uh, to make sure I was giving , uh, my distributors the right supports. But the key is really to create a team. And of course, when you are asking about investments, it's not like I've got a distributor, is got to pay for everything in his , uh, in his country. You've got to differentiate, again, two things. If your product is already well accepted and sold in the country, and you are making a lot of money in this country, well, you know that if you change your distributor, the new one in that case will ge generate , uh, enough margin to make investments. But when it comes to launching and entering into a new market where your products haven't been sold, you cannot just, you know, shrink your strategy to, okay, I'm going to find a distributor each time I'm going to this country will pay for everything related to permission to Congress. Uh , it will pay all my meals. Uh , if I, I've got to be basic, because sometimes that's how people, you know , uh, just for fee , uh, you know, the way it works with a distributor, that's not how it works. A distributor, again, has to be your relay in, in this country, and you cannot ask him to do all the investments right from the start to make, you know , uh, your product successful in, in , uh, in this country. So you've got to show him full support, and you've got to share also the expenses for doing the promotion. Otherwise, I think it's going to be very difficult for, for your product, your company, to have success in a specific country. And again, you've got to , uh, right from the start show , uh, your improve your partner, that you are behind him. And again, being behind a partner, it's not only giving him the exclusivity or I would say a distribution, but also a financial support when needed.

Julio Martinez: 44:00

Excellent, Nicholas , very good description. So let's move on to pricing. Do you think Latin America is a price sensitive , uh, region?

Nicolas Poutrain: 44:08

Yes and no. Yes, in some countries, mainly in , uh, in Central America or countries like , uh, I would say Peru and Colombia , yes, is also , uh, price sensitive, but then it's a bit like in Japan, I'm making a , a comparison with Japan where everything is expensive. We've got a big office in Japan. And in Japan, everything is expensive because also these regulatory , uh, requirements in Japan, for instance, are very demanding and expensive at the end. What I mean is that it can be so difficult, for instance, to sell in Brazil. And, and the process can be so long, like , uh, in other countries that sometimes, mainly Brazil, you can sell at very high prices because , uh, the market in a way leads you to have this kind of prices because of, again, the hurdles , uh, you've got to face when entering the market. And then you've got a country like , uh, like , uh, Chile where the pricing in Chile is as high as in Europe, I would say in our equipment, we are maybe , uh, selling , uh, at higher prices in Chile than , uh, we do in Europe. And , uh, in the us that's a funny , uh, market to us , uh, in that sense. But then of course, if you go to Mexico, Argentina, Ecuador, Peru , uh, no Ecuador, no , uh, Peru and , uh, and Colombia , these are markets that are quite , uh, price sensitive. Why did I say not in Ecuador? It's because in Ecuador, sometimes you must face , uh, uh, a lot of , uh, corruption. This is also the reality. We cannot , uh, be blind , uh, about this. Uh, you've got also some corruption in , uh, in all Latin America that makes sometimes, you know , uh, prices to be higher that we could think. But , uh, then of course, for matters of compliance , uh, all companies cannot cope with these , uh, these issues. But it makes sometimes the corruption, the pricing , uh, strategy of a market being higher than expected, and it can help in some situations.

Julio Martinez: 46:22

Very interesting. Yeah, corruption is definitely an issue, and that's usually a question that I ask , uh, my guests on the show, but you already answered that, so thank you for , uh, jumping ahead a little bit. Um, the other topic that I wanted to ask you about is reimbursement. Uh, what's been your experience with reimbursement in Latin America?

Nicolas Poutrain: 46:44

Okay, reimbursement. Well , uh, if , uh, you are dealing with products that have to do with , uh, regular treatments, modalities already , uh, benefiting from a codification, a code, in that case , uh, reimbursement is not an issue. As a matter, as a , an example, in Mexico , uh, one of our technology had a reimbursement for , uh, the past 30 years. And , uh, I must say that , uh, it should then change a lot. But then based on the economy , uh, of the market, sometimes, like in Brazil, you can have big fluctuations in the reimbursement of some of , uh, of the modalities of the treatment. But again, when it has to do with regular standard , uh, products, reimbursement in , in all these countries is not , is not an issue. And , and once you've got, again, hospitals , uh, that have interest in your products or physicians, they will make sure that , uh, your , your product will get reimbursed in case there is nothing. The biggest issue is o of course, with , uh, new technologies, new products, new procedures , uh, and we've got this issue today with our product that treats , uh, prostate cancer, our focal one. And then what it has to do with new technologies, well , first of all, it has to be out of pocket while private treatments, so the patients, they have to pay for the treatments, and it can take a lot of time before you get your , uh, product approval for reimbursement. And , uh, I know that in Mexico it's very long in , uh, Brazil, it's very long. Well , in most of the countries it takes some times then, well, the main issue in Latin America is , uh, depending on the country where you are, for instance, Mexico , uh, 80% of the market in Mexico, it's mainly , uh, well , 70 maybe percent, it's mainly , uh, public. And then , uh, private, you go to , uh, Brazil, and I would say that for your market access, 80% of the market will be private. So depending on how the, the market, the medical industry , uh, or the medical scenery is organized in each of these countries, while if it's a private market, reimbursement won't be that much a problem. But , uh, if you get into a market where it's almost like everything public, like you go to cost Rica, which is a small country, and 95% of this market, it's , uh, it's public, then if you've got a new technology, non-reimbursed, then it's going to be a problem .

Julio Martinez: 49:20

Problem . Okay, very good. Uh , Nicholas , so before we close the show, what about the cultural differences between Europe or the US and Latin America? I mean, what do you think about the way people do business in Latin America?

Nicolas Poutrain: 49:35

Well, I'm lucky , uh, as a French guy, and this is very important, that's why I just mentioned it, not to be cocky, but , uh, mentioned it when you, you , you gave my , uh, biography a bit, but , uh, I speak Spanish and Portuguese, and if you want to work with these countries, there is, and it's not only Latin America, it's worldwide. There is nothing better than speaking, you know, their native language. If you want to make business, people will really thank you a lot. The interest , uh, you have for, for the country and the efforts done to learn their language, that makes it much easier to , uh, to do business. Then in France, we are a Latin culture. So even if we are not as Latin as , uh, Spanish people, Italian people, and, and tha American people, Latin American people, you've got a lot of connections between , uh, our culture and the culture in , uh, in Latin America being now based in , in the us I can see that for the American people walking in TAs , America, it can be a bit more difficult because they don't have the same relation and culture as , as we have. America has really , uh, a different culture that makes the country that powerful. It's different, but I can see now that all , uh, my colleagues I've got in the US and competitors, in direct competitors now going to South America, make sure to have the right people to, to work with Latin America, of course, to make sure these people speak , uh, speak Spanish and Portuguese when they can, or they will hire people from South America that live in , uh, Latin America, that live in the US to make the job, to make sure that they will have , uh, good connections with the partners in Latin America. But again, the culture in , uh, Latin America is just fantastic to me. Uh, I , I've always been in love with this countries , that's why I finished my studies in , uh, in Mexico, and to me, it's very easy to see , uh, to do , uh, when I say easy, it's in the relations. Yes, it's easy to do business in , uh, in Latin America, of course, you've got corruption, you've got many and negative things, but we've got that also in France , uh, worldwide, you always have setbacks and, and good things, you know, but the culture, again, makes it , uh, easy to do business in , uh, in this countries people , uh, you are working with are always very nice people, open people, and , uh, they've got a fantastic culture.

Julio Martinez: 52:07

Excellent. Uh, Nicola , I'm glad you think that way about Latin America. Uh , well, before we sign off for today, Nicola , do you have any final thoughts , uh, more sos of wisdom or other musings, <laugh> for our listeners? In other words, what will you say to the CEO of a small or midsize medical device company from the US or Europe or Japan , uh, that hasn't looked at Latin America, or is just starting to look or explore the region as a potential market?

Nicolas Poutrain: 52:39

I would tell them that they don't have to minimize the potential of South America. It's a great market, and , uh, and I think they've got to explore , uh, some of South America and to give to South America a lot of attention. Of course, if you are a European , uh, company , uh, just getting started, you've got to prioritize your, your actions and go first to , uh, the easiest market available , uh, around , uh, your company, like in the us . But once you want to go to exports and , uh, international, I think to my opinion that South America is one of , uh, the atheist market again, to go because of the culture, it's not difficult, but to do so, you've got to get prepared. You've got to have a good regulatory department ready to spend time with your local partners to , uh, to , and well , I have patients to, to , uh, get your products , uh, your products registered, but it's not very expensive to do so, so you've got to have the right people, the right people in your company in sales to deal with us America. So make sure your people will speak Spanish or Portuguese to go to Brazil if you can do it , uh, because the language is very important. And of course, to have people who like these countries , but there is really a big potential in these countries. The level, again, of medicine is high. Uh, if you take like Brazil , uh, the surgeons in Brazil are amongst the best worldwide just because this is a country with 200 , uh, million inhabitants. So it makes , uh, the level of , uh, of medicine very high. And , uh, these companies who want to go to South America don't have to be afraid. Uh, these countries, they have all , uh, the infrastructures again, and level of , uh, medicine of evidence to go with , uh, with your products. The only setback of South America, as I told it, that's a continent with which you can fall in love very easily. But don't forget that this can , these countries also face crisis maybe twice , uh, per decade , a big EE economical crisis. So it's really like a rollercoaster sometimes. This is, I would say the , the setback of , uh, Latin America, but that's maybe also because we like it. That's how it is. You've got to get prepared that you will have sometimes very good years , and sometimes it'll be , uh, a bit , uh, more difficult. But , uh, these countries , uh, at the end will , uh, will always recover.

Julio Martinez: 55:16

Excellent. Nicola , fantastic. Um, description of the region. Fantastic interview. Thank you so much. I am really, really glad that we were able to record this episode. You are full of knowledge and experience in Latin America, and , uh, it's been great. So how can listeners connect with you?

Nicolas Poutrain: 55:36

Well , uh, it's very easy, you know, they can go onto , uh, onto LinkedIn and find , uh, my profile. You know, you just type , uh, text my , uh, my name Nicholas Ra in LinkedIn . They can just connect with me there. And , uh, you know, I'm, I'm pretty fast , uh, with , uh, all these social , uh, social networks and , uh, if anybody wants just to, to get in touch with me. So he contacts with me, and if , uh, they have questions about how to , uh, get access to , uh, the markets in Latin America, if I can give them some tips, some information, I will be more than , uh, delighted to have .

Julio Martinez: 56:15

Excellent, Nicholas , thank you for that. So that's the end of the show, and I look forward to connecting with you again sometime in the, the future. Hopefully we can record another episode , uh, with another topic , um, starting to think about other , uh, topics to include here. Probably we could do , uh, individual countries and to get more into the details, things of that nature. So I thank you again, and , uh, have a great day. Uh, be safe.

Nicolas Poutrain: 56:41

Thank you. Thank you , uh, again, Julio, for giving me this , uh, chance to, to speak and to share , uh, this experience with you. It's been really , uh, a very , uh, nice time and , uh, and , uh, I , I will be more than happy to be there , uh, again with you.

Julio Martinez: 56:55

Excellent, Nicholas . Bye-Bye. Take care .

Nicolas Poutrain: 56:57

Bye-Bye bye-Bye.